20 Participants Needed

Fecal Microbiota Transplantation for Kidney Cancer

(PERFORM Trial)

RF
Overseen ByRicardo Fernandes, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are on systemic steroid therapy or antibiotics before the trial. It's best to discuss your specific medications with the trial team.

Is fecal microbiota transplantation (FMT) safe for humans?

Fecal microbiota transplantation (FMT) is generally considered safe and well-tolerated, even in high-risk patients, with most short-term risks being mild and related to delivery methods. However, long-term side effects are not well-established, and serious adverse events have been linked to inadequate screening for multi-drug resistant organisms in some stool banks.12345

How is fecal microbiota transplantation different from other treatments for kidney cancer?

Fecal microbiota transplantation (FMT) is unique because it involves transferring healthy gut bacteria from a donor to a patient to restore the balance of microorganisms in the gut, which may influence the body's immune response and metabolism. Unlike traditional cancer treatments like chemotherapy or radiation, FMT focuses on altering the gut microbiome to potentially impact cancer and its complications.678910

What is the purpose of this trial?

Cancer immunotherapy has been largely adopted in oncology patient management in the last decade. The deep and long responses to immunotherapy have accelerated the approval of these drugs across multiple disease sites. However, these agents can also be toxic to patients, meaning, the patient will have to discontinue treatment and outcomes could be negatively affected. Recently, a combination of two immunotherapy drugs, ipilimumab and nivolumab (ipi/nivo), has been approved for the treatment of intermediate and poor-risk renal cell carcinoma (RCC) patients. This powerful combination provides survival benefit, however, it can also be highly toxic leading to discontinuation of this treatment.There has been some evidence that these otherwise toxic drugs can be better tolerated by altering the composition of the patients gut bacteria to create a more diverse and healthy microbiome. The current study will involve Fecal Microbiota Transplantation (FMT) before the start of the immunotherapy combination, and during the first two cycles of ipilimumab treatment (the more toxic agent) as supportive therapy to prevent toxicity associated with the ipi/nivo combination.The goal of this project is to study the safety of such FMT combination treatment and reduce occurrence of immune-related toxicities in patients, allowing them to continue their cancer treatments in the hopes of a better outcome. The investigators will also be looking at changes in the immune populations, microbiome profile of patients, response to treatment, and patient survival as secondary objectives.

Research Team

RF

Ricardo Fernandes, MD

Principal Investigator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

SM

Saman Maleki, PhD

Principal Investigator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Eligibility Criteria

This trial is for adults with advanced or metastatic renal cell carcinoma, specifically those at intermediate or poor risk. Participants must be in good physical condition (KPS ≥70%), able to swallow capsules, and have not had certain prior treatments including systemic therapy for RCC. Pregnant individuals, those with immunodeficiency, chronic intestinal diseases, active infections requiring systemic therapy, or a history of serious autoimmune disease are excluded.

Inclusion Criteria

Understand non-infectious risks associated with FMT administration and that the long term data regarding safety risks of FMT are lacking
Able to provide written informed consent
I am able to care for myself but may not be able to do active work.
See 6 more

Exclusion Criteria

I haven't had radiation for bone metastasis in the last 2 weeks or any radiation in the last 4 weeks.
I have not received a live vaccine in the last 4 weeks.
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
See 14 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Fecal Microbiota Transplantation

Participants receive Fecal Microbiota Transplantation before the start of immunotherapy and during the first two cycles of ipilimumab treatment

10 weeks
4 visits (in-person)

Immunotherapy Treatment

Participants receive combination treatment with ipilimumab and nivolumab

28 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Fecal Microbiota Transplantation
Trial Overview The study tests if Fecal Microbiota Transplantation (FMT) can reduce the side effects of ipilimumab/nivolumab immunotherapy in kidney cancer patients. The goal is to allow patients to tolerate their cancer treatment better by altering gut bacteria before and during the first two cycles of this powerful but potentially toxic drug combination.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Fecal Microbiota TransplantationExperimental Treatment1 Intervention
Fecal microbiota transplantation combined with approved standard of care treatment with nivolumab and ipilimumab.

Find a Clinic Near You

Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials
686
Recruited
427,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials
678
Recruited
421,000+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials
668
Recruited
424,000+

Lawson Health Research Institute

Lead Sponsor

Trials
684
Recruited
432,000+

Academic Medical Organization of Southwestern Ontario

Collaborator

Trials
17
Recruited
1,600+

Findings from Research

Fecal microbiota transplantation (FMT) is highly effective for treating Clostridium difficile infection (CDI), with a 90% resolution of diarrhea reported in 867 patients across 33 studies, and a 94% resolution after repeated FMT in a randomized controlled trial with 16 participants.
FMT shows promise in treating ulcerative colitis, with remission rates varying from 0% to 68% in 106 patients, while its efficacy in Crohn's disease, chronic constipation, pouchitis, and irritable bowel syndrome remains inconclusive due to limited data.
Fecal microbiota transplantation as novel therapy in gastroenterology: A systematic review.Rossen, NG., MacDonald, JK., de Vries, EM., et al.[2022]
Fecal microbiota transplantation (FMT) is a generally safe and well-tolerated procedure for treating recurrent Clostridioides difficile infections, even in high-risk patients, with most short-term risks being mild and related to delivery methods.
Recent concerns have emerged regarding serious adverse events linked to FMT products from stool banks that do not screen for multi-drug resistant organisms, highlighting the need for improved safety protocols.
Fecal Microbiota Transplantation: Is It Safe?Park, SY., Seo, GS.[2021]
A study involving 123 patients who underwent fecal microbiota transplantation (FMT) over a median follow-up of 30.3 months showed that FMT has an excellent long-term safety profile, with new medical conditions being unlikely to be related to the procedure.
In patients with recurrent Clostridioides difficile infection, FMT was associated with a significantly higher survival probability compared to those treated with antibiotics, indicating its efficacy in improving long-term health outcomes.
Long-Term Safety Outcomes of Fecal Microbiota Transplantation: Real-World Data Over 8 Years From the Hong Kong FMT Registry.Yau, YK., Lau, LHS., Lui, RNS., et al.[2023]

References

Fecal microbiota transplantation as novel therapy in gastroenterology: A systematic review. [2022]
Fecal Microbiota Transplantation: Is It Safe? [2021]
Long-Term Safety Outcomes of Fecal Microbiota Transplantation: Real-World Data Over 8 Years From the Hong Kong FMT Registry. [2023]
[Current research progress and thinking of fecal microbiota transplantation for the treatment of gastrointestinal disorders]. [2020]
Efficacy of Fecal Microbiota Transplantation for Patients With Irritable Bowel Syndrome at 3 Years After Transplantation. [2022]
Fecal microbiota transplantation in a kidney transplant recipient with recurrent urinary tract infection. [2019]
Intestinal microbiota and the efficacy of fecal microbiota transplantation in gastrointestinal disease. [2022]
Therapeutic Perspectives for Microbiota Transplantation in Digestive Diseases and Neoplasia-A Literature Review. [2023]
Fecal microbiota transplantation in disease therapy. [2020]
10.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Fecal microbiota transplantation: donor selection criteria, storage and preparation of biomaterials (review of current recommendations)]. [2022]
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